FX.co ★ Kyverna Gets FDA RMAT Designation For KYV-101 In Refractory Stiff-Person Syndrome Treatment;stock Up

Kyverna Therapeutics Inc. (KYTX) has announced that its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with refractory stiff-person syndrome.

The RMAT designation will enable Kyverna to benefit from expert guidance on efficient drug development and the utilization of surrogate endpoints from senior FDA officials.

Currently, KYV-101 is being evaluated in company-sponsored, open-label Phase 1/2 and Phase 2 trials within the United States and Germany, focusing on two main areas of autoimmune disease: rheumatology and neurology. Additionally, KYV-101 is under investigation in trials initiated by researchers for multiple indications across various regions.

On Monday, KYTX closed regular trading at $9.91, showing an increase of $0.12 or 1.23%. The stock further rose by $0.74 or 7.47% during after-hours trading.